Celecoxib chemical structure
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Celebrex

Celecoxib is a non-steroidal anti-inflammatory drug (NSAID) used in the treatment of osteoarthritis, rheumatoid arthritis, acute pain, painful menstruation and menstrual symptoms, and to reduce numbers of colon and rectum growths polyps in patients with familial adenomatous polyposis. It is marketed by Pfizer under the brand name Celebrex. more...

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Pharmacology

Celecoxib is a highly selective COX-2 inhibitor and primarily inhibits this isoform of cyclooxygenase, whereas traditional NSAIDs inhibit both COX-1 and COX-2. Celecoxib is approximately 10-20 times more selective for COX-2 inhibition over COX-1. In theory, this specificity allows celecoxib and other COX-2 inhibitors to reduce inflammation (and pain) while minimizing gastrointestinal adverse drug reactions (e.g. stomach ulcers) that are common with non-selective NSAIDs. It also means that it has a reduced effect on platelet aggregation compared to traditional NSAIDs.

Adverse effects

Aside from the incidence of gastric ulceration, celecoxib exhibits a similar adverse drug reaction (ADR) profile to other NSAIDs.

Gastrointestinal ADRs

In theory the COX-2 selectivity should result in a significantly lower incidence of gastrointestinal ulceration than traditional NSAIDs. The main body of evidence touted to support this theory were the preliminary (6 month) results of the Celecoxib Long-term Arthritis Safety Study (CLASS) as published in 2000, which demonstrated a significant reduction in the incidence of gastrointestinal ulceration in those taking celecoxib versus ibuprofen or diclofenac. (Silverstein et al, 2000) The final (12 month) results from the CLASS study, however, did not indicate any advantage of celecoxib over the other NSAIDs in the study. (Malhotra, Shafiq & Pandhi, 2004)

Cardiovascular risk

The withdrawal of rofecoxib from the market in 2004 due to an increased risk of adverse cardiovascular events led to the suspicion that this was a class effect. Indeed an increased risk of heart attack and stroke was found in a National Cancer Institute study studying the use of 400-800 mg celecoxib daily for the prevention of colorectal adenoma (relative risk 2.3-3.4 vs placebo). (Solomon et al., 2005)

There is still much conjecture, however, as to whether this risk is significant for the majority of patients being treated with lower doses for osteoarthritis. The overall safety profile of celecoxib, including its cardiovascular, renal and digestive effects, will be compared to traditional anti-inflammatoris (naproxen and ibuprofen) in a randomized trial of 20,000 high risk patients that is due to begin in 2006 (PRECISION study sponsored by Pfizer)

Allergy

Celecoxib contains a sulfonamide moiety and may cause allergic reactions in those allergic to other sulfonamide-containing drugs. This is in addition to the contraindication in patients with severe allergies to other NSAIDs.

Commercial history

Celecoxib was developed by G. D. Searle & Company and marketed jointly by Searle and Pfizer under the brand name Celebrex. Searle was acquired by Pharmacia, which was then acquired by Pfizer, in part so that Pfizer could take full control of Celebrex.

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Labeling changes for arthritis drug - Updates - Celebrex
From FDA Consumer, 9/1/02

The FDA has approved labeling changes for Celebrex (celecoxib) based on the results of the Celecoxib Long-Term Arthritis Safety Study (CLASS).

CLASS evaluated about 4,000 people with osteoarthritis (OA) and rheumatoid arthritis (RA) treated with Celebrex at doses of 400 mg twice a day (twice the highest approved dose of Celebrex to treat RA), compared to about 4,000 people treated with standard doses of ibuprofen or diclofenac. These are non-steroidal anti-inflammatory drugs (NSAIDs).

The use of low-dose aspirin for prevention of heart attack and stroke (up to 325 milligrams per day) was permitted during the study.

The results of the CLASS study did not support a change in the label related to serious gastrointestinal (GI) events, but important information about the drug was obtained. Inclusion of patients on low-dose aspirin in the study was valuable for the safety assessment of Celebrex. But the use of aspirin, a drug known to cause stomach ulcers and bleeding, may have obscured the ability to accurately compare the GI safety of Celebrex to other NSAIDs.

The agency concluded that the drug labeling for Celebrex should continue to include the standard warning about risks associated with all NSAIDS, including risks of GI ulceration, bleeding and perforation.

The FDA also determined that safety data from CLASS should be incorporated into the labeling. The overall safety of Celebrex at twice the highest approved dose for rheumatoid arthritis was similar to commonly used doses of ibuprofen and diclofenac. Despite the high dose used, the rates of hypertension, swelling, and serious adverse events, including cardiovascular problems such as heart attacks, were no higher in people treated with Celebrex than in people treated with ibuprofen or diclofenac. People taking low-dose aspirin and Celebrex had a higher rate of upper GI events than those taking Celebrex alone.

The geriatric section of the labeling will include new information about the risk of serious GI and kidney effects in elderly people. Such findings have also been reported with other NSAIDs, and it is known that elderly people are at higher risk of GI ulcers and bleeding. Another observation reported in the labeling is that patients treated with Celebrex experienced less anemia than patients taking ibuprofen or diclofenac.

Pharmacia of Peapack, N.J., manufactures Celebrex. The drug was approved to treat rheumatoid arthritis and osteoarthritis in 1998.

COPYRIGHT 2002 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group

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